RESUMEN
BACKGROUND: The stability of ophthalmic preparations in multidose containers is influenced by the preservative as well as the stability of the active ingredient. Unstable drugs may require refrigeration to preserve their active ingredient level and they are more likely to degrade over time, therefore becoming more susceptible to degradation based on patient mishandling. The purpose of this study was to determine the degree of molecular degradation that occurs in bimatoprost and latanoprost in a patient-use setting. METHODS: This was an open-label, laboratory evaluation of the relative stability of bimatoprost and latanoprost. Patients presently using bimatoprost (n = 31) or latanoprost (n = 34) were identified at 2 clinical sites in Brazil. Patients were instructed to use and store their drops as usual and return all used medication bottles between day 28 and day 34 after opening. RESULTS: Bimatoprost demonstrated no degradation, but latanoprost degraded at various levels. The mean age of bimatoprost was 43.0 +/- 3.4 days and the mean age of latanoprost was 43.9 +/- 2.8 days (P = .072). The mean percentage of labeled concentration was 103.7% in the bimatoprost bottles and 88.1% in the latanoprost bottles (P < 001). CONCLUSION: This study showed that bimatoprost maintained > or =100% concentration throughout the study period while latanoprost did not.
Asunto(s)
Amidas/química , Antihipertensivos/química , Cloprostenol/análogos & derivados , Estabilidad de Medicamentos , Glaucoma/tratamiento farmacológico , Prostaglandinas F Sintéticas/química , Adulto , Amidas/administración & dosificación , Amidas/normas , Antihipertensivos/administración & dosificación , Antihipertensivos/normas , Bimatoprost , Cloprostenol/administración & dosificación , Cloprostenol/química , Cloprostenol/normas , Embalaje de Medicamentos , Estudios de Seguimiento , Humanos , Presión Intraocular/efectos de los fármacos , Latanoprost , Soluciones Oftálmicas , Prostaglandinas F Sintéticas/administración & dosificación , Prostaglandinas F Sintéticas/normas , Estudios Retrospectivos , Estaciones del Año , Temperatura , Factores de TiempoRESUMEN
PURPOSE: To assess the functional status and well-being in glaucoma patients who live in a developing country. METHODS: Cross-sectional case control study, comprising 102 glaucoma patients and 58 controls. All subjects were administered the Medical Outcomes Study 36-item short-form survey (SF-36). SF-36 scores for study and control groups were compared. Statistical analysis included Student's t-test for score data and Student's t- and chi-square tests for demographic data. RESULTS: Patients with glaucoma had significantly lower scores than healthy control subjects (p < 0.05) in five domains of the SF-36 survey (physical functioning, role-emotional, bodily pain, social functioning and mental health). Bodily pain was the domain with the lowest score. CONCLUSIONS: Patients with glaucoma who live in a developing country have less functional status than non-glaucomatous patients.